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IRCT20240916063060N1 IRCT 2025-01-26 Tabriz University of Medical Sciences Effect of glutamine in breast cancer Effect of glutamine supplementation on cardiomyopathy biomarkers, body composition changes and quality of life in breast cancer patients undergoing chemotherapy: a clinical trial study 2025-02-19 anticipated 46 Complete https://irct.ir/trial/79010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization will be used. The size of all blocks will be equal. The randomization tool will be Random Sequence Generation (RAS) software. For concealment, random allocation using sealed opaque envelopes will be used, Blinding description: All the packages containing supplements and placebo will be coded with numbers 1 or 2 by someone outside the study, and people will be assigned to one of the groups receiving code 1 or 2 based on the blocks. As a result, the researcher and the patients will be blinded. 3 سرطان پستان. Intervention 1: Intervention group: The intervention group will receive 5 grams of glutamine powder daily for a duration of 8 weeks. Glutamine will be purchased from Karen Company. All patients will be monitored for glutamine consumption using a weekly checklist and reminder messages. Intervention 2: Control group: The control group will receive 5 grams of placebo powder daily for a duration of 8 weeks. The placebo will be purchased from Karen Company. All patients will be monitored for placebo consumption using a weekly checklist and reminder messages. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available.
public Ahmadreza Rasouli
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences, Attar Neishabouri St., Tabriz, Iran
Tabriz Iran (Islamic Republic of) 0000000000 +98 24 3356 1790 ahmadrasoulinut@yahoo.com Tabriz University of Medical Sciences scientific Hamid Khederlou
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3356 1790 ham_khed@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate Adult women (over 18 years of age) with breast cancer at the beginning of chemotherapy who referred to the Mehraneh Charity Association of Zanjan. 18 years no limit Female Report of food intake that is too much or too little (4200-800) kcal Body mass index less than 18.5 and more than 45 Drug use or alcohol consumption at least once a week Pregnancy and lactation Having CKD, CAD, MI, ESRD, DM, Liver disease C50 Malignant neoplasm of breast Prevention Placebo Intervention group: The intervention group will receive 5 grams of glutamine powder daily for a duration of 8 weeks. Glutamine will be purchased from Karen Company. All patients will be monitored for glutamine consumption using a weekly checklist and reminder messages. Control group: The control group will receive 5 grams of placebo powder daily for a duration of 8 weeks. The placebo will be purchased from Karen Company. All patients will be monitored for placebo consumption using a weekly checklist and reminder messages. Serum cTnT level. Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: ELISA. Serum CK-MB level. Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: ELISA. Echocardiography test. Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: Echocardiography device. Body composition analysis. Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: Body composition analyzer. Food frequency. Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: Food frequency questionnaire. Anthropometric index(weight, height, and Body Mass Index). Timepoint: Before the start of the study and 2 months after the intervention. Method of measurement: Scale and Stadiometer. Quality of life. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Questionnaire (QLQ-C30). Tabriz University of Medical Sciences Approved 2025-01-13 Ethics committee of Tabriz University of Medical Sciences Gholgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)